Fecal microbiota transplantation for treating gastrointestinal graft-versus-host disease
Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
This study is testing whether a treatment using healthy donor stool can help patients with gastrointestinal graft-versus-host disease feel better after their stem cell transplant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT03819803 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) to treat patients suffering from gastrointestinal acute graft-versus-host disease (GI-aGvHD) following allogeneic hematopoietic stem cell transplantation (ASCT). The study focuses on patients with steroid-refractory GI-aGvHD who exhibit reduced bacterial diversity in their stool microbiota. FMT involves the infusion of healthy donor stool into the patient's gastrointestinal tract via colonoscopy, aiming to restore a healthy microbiome and alleviate symptoms of GI-aGvHD. The trial is designed to assess the efficacy and safety of this intervention in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients experiencing their first episode of steroid-refractory GI-aGvHD with confirmed dysbiosis in their stool microbiota.
Not a fit: Patients with recurrent episodes of GI-aGvHD or those who have complications from previous colonoscopies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and survival rates for patients suffering from GI-aGvHD.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation in treating various gastrointestinal disorders, suggesting potential success for this approach in GI-aGvHD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * first episode of histologically confirmed, steroid-refractory GI-aGvHD * reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement * eligibility for repeated colonoscopic procedures * informed consent Exclusion Criteria: * complications during a previous colonoscopy * recurrent episode of GI-aGvHD * lacking cardiopulmonary fitness for repeated colonoscopic procedures * septic infection * acute extraintestinal organ failure (excluding bone marrow) * mechanical ileus
Where this trial is running
Graz, Styria
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz — Graz, Styria, Austria (Recruiting)
Study contacts
- Principal investigator: Peter Prof. Dr. Neumeister — Department of Internal Medicine, Division of Hematology, Medical University of Graz
- Study coordinator: Walter DDr. Spindelboeck
- Email: walter.spindelboeck@medunigraz.at
- Phone: 0043 316 385 30195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.